Aethlon Medical Announces Data Supported Strategy to Increase Hepatitis-C (HCV) Cure Rates
March 25 2009 - 7:30AM
PR Newswire (US)
SAN DIEGO, March 25 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc.
(OTC Bulletin Board: AEMD) today announced clinical data that
supports the advancement of the Aethlon Hemopurifier(R) as an
adjunct therapy to increase Hepatitis-C (HCV) cure rates. The
Hemopurifier(R) is a first-in-class medical device that assists the
immune response in combating infectious disease through real-time
therapeutic filtration of infectious viruses and immunosuppressive
proteins. In HCV care, the device inhibits viral replication
through selective elimination of HCV in circulation and assists to
preserve immune cells by removing toxic proteins shed from the
surface of HCV. (Photo:
http://www.newscom.com/cgi-bin/prnh/20090325/LA88762-a) (Logo:
http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b) Aethlon
disclosed that data resulting from over 20 HCV treatments indicates
an average viral load reduction of 41% during each four-hour
Hemopurifier(R) treatment. In the studies, average pre-treatment
viral load of 22,868,000 HCV virus copies/ml blood (cpm) was
reduced on average by 9,300,000 cpm during the course of each
treatment. Based on this data, Aethlon predicts that short-term
continuous Hemopurifier(R) treatment can reduce viral load to low
to undetectable levels, thus improving the likelihood that HCV
patients achieve a sustained virological response (SVR) from the
current interferon-ribavirin standard of care and other candidate
therapies. HCV infection is considered cured when SVR extends
beyond six months. At present, less than 50% of HCV patients
respond to interferon-ribavirin therapy. Additionally, there is a
direct correlation between low viral load at onset of
interferon-ribavirin therapy and increased cure rates. Based on
data analyzed from each four-hour Hemopurifier(R) treatment,
Aethlon projects that a patient with a high viral load of 7 million
iu/ml would be reduced to undetectable HCV levels after
approximately three days of continuous Hemopurifier(R) treatment.
This corresponds to a 4.06 log reduction or an 11,000-fold decrease
in viral load. An HCV patient with a moderate viral load of 2
million iu/ml would be projected to reach undetectable levels in
approximately 2.5 days of continuous treatment. All of the studies
were conducted in highly health compromised HCV infected patients
who suffer from end-stage renal disease (ESRD) requiring regular
kidney dialysis treatment. In these treatment studies, the
Hemopurifier(R) inhibited the progression of HCV infection in ESRD
patients when included during dialysis treatment administered
thrice weekly for four-hours. The studies were conducted at the
Fortis Hospital in Delhi, India. About Hepatitis-C Virus HCV is a
leading cause of chronic liver disease and liver transplants. The
World Health Organization (WHO) estimates that nearly 180 million
people worldwide, or approximately 3% of the world's population,
are infected with HCV. 130 million of these individuals are chronic
HCV carriers who are at increased risk of developing liver
cirrhosis or liver cancer, approximately 15 million of whom are in
the United States, Europe and Japan. The CDC has reported that
almost four million people in the United States have been infected
with HCV, of whom 2.7 million were chronically infected.
Approximately 2.6%, or 71,000, of these HCV patients are treated
each year. Although chronic HCV infection varies greatly in its
course and outcomes, 70% of chronically infected patients develop
some form of chronic liver disease, including, in some cases,
cirrhosis or liver cancer. In the United States, the current
standard of care for the treatment of HCV is a combination of
pegylated interferon and a nucleoside analog named ribavirin.
According to WHO, treatment with interferon in combination with
ribavirin is effective in 30% to 50% of patients, while interferon
alone is effective in approximately 10% to 20% of patients. In HCV
genotypes 1a and 1b, which account for over 70% of HCV infections
in the US, less than 50% of these patients respond to standard
therapy consisting of pegylated interferon plus ribavirin. In
addition, these therapies have serious side effects that include
fatigue, bone marrow suppression, anemia and neuropsychiatric
effects. As a result of the limited benefits and serious side
effects of existing therapies, significant value is placed on
promising antiviral strategies to fight HCV. The Aethlon
Hemopurifier(R) is positioned to improve the benefit of the current
interferon-ribavirin standard of care, as well as other candidate
HCV drug therapies demonstrating promise in clinical studies. About
Aethlon Medical Aethlon Medical creates diagnostic and therapeutic
filtration devices to improve the health of individuals afflicted
with infectious disease and cancer. Aethlon's lead product, the
Hemopurifier(R), is a first-in-class artificial adjunct to the
immune system proven to capture infectious viruses and
immunosuppressive particles from the human circulatory system. The
device targets to inhibit disease progression of Hepatitis-C Virus
(HCV) and Human Immunodeficiency Virus (HIV), and serves as a
broad-spectrum treatment countermeasure against bioterror and
emerging pandemic threats. The Hemopurifier(R) also holds promise
in cancer care, as research studies verify the Hemopurifier(R)
effectively captures immunosuppressive exosomes that are secreted
by tumors to kill-off immune cells. At present, over sixty-five
(65) Hemopurifier(R) treatments (representing approximately 260
hours of treatment time) have been conducted in multi-site studies
at the Apollo Hospital, Fortis Hospital, and Sigma New-Life
Hospital in India. The studies enrolled end-stage renal disease
(ESRD) patients infected with either HCV or HIV. In addition to
establishing treatment safety, robust viral load reductions have
been reported in both HCV and HIV infected individuals. Research
studies have also demonstrated the Hemopurifier(R) is effective in
capturing a broad-spectrum of viruses untreatable with drug
therapy, including several of world's deadliest bioterror and
pandemic threats. These include: Dengue hemorrhagic fever (DHF),
Ebola hemorrhagic fever (EHF), Lassa hemorrhagic fever (LHF), H5N1
avian influenza (Bird Flu), the reconstructed 1918 influenza virus
(r1918), West Nile virus (WNV), and Vaccinia and Monkeypox (MPV),
which both serve as models for human smallpox infection. The
studies were conducted with the assistance of researchers
representing: The U.S. Army Medical Research Institute of
Infectious Diseases (USAMRIID); The Centers for Disease Control and
Prevention (CDC); The National Institute of Virology (NIV); The
Battelle Biomedical Research Center (BBRC); and The Southwest
Foundation for Biomedical Research (SFBR). Beyond therapeutic
market opportunities, Aethlon is leveraging principles underlying
the Hemopurifier(R) technology platform to establish a pipeline of
clinical and research diagnostic products and services. Additional
information regarding Aethlon Medical can be accessed online at
http://www.aethlonmedical.com/. Certain of the statements herein
may be forward-looking and involve risks and uncertainties. Such
forward-looking statements involve assumptions, known and unknown
risks, uncertainties and other factors which may cause the actual
results, performance or achievements of Aethlon Medical, Inc. to be
materially different from any future results, performance, or
achievements expressed or implied by the forward-looking
statements. Such potential risks and uncertainties include, without
limitation, the capability of the Hemopurifier(R) to reduce viral
loads and other disease conditions, the Company's ability to raise
capital when needed, the Company's ability to complete the
development of its planned products, the ability of the Company to
obtain FDA and other regulatory approvals permitting the sale of
its products, the Company's ability to manufacture its products and
provide its services, the impact of government regulations, patent
protection on the Company's proprietary technology, product
liability exposure, uncertainty of market acceptance, competition,
technological change, and other risk factors. In such instances,
actual results could differ materially as a result of a variety of
factors, including the risks associated with the effect of changing
economic conditions and other risk factors detailed in the
Company's Securities and Exchange Commission filings.
http://www.newscom.com/cgi-bin/prnh/20090325/LA88762-a
http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b
http://photoarchive.ap.org/ DATASOURCE: Aethlon Medical, Inc.
CONTACT: Prashant Mehta, Ph.D., Director of Business Development,
+1-858-459-7800, ext. 303, , Jim Frakes, Senior VP Finance,
+1-858-459-7800 ext. 300, , Jim Joyce, Chairman, CEO,
+1-858-459-7800, ext. 301, , all of Aethlon Medical, Inc. Web Site:
http://www.aethlonmedical.com/
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